Blood Glucose in Pregnant Non-diabetic Women During Treatment with Betamethasone for Fetal Lung Maturation

Blood Glucose Levels in Pregnant Non-diabetic Women During Treatment with Betamethasone for Fetal Lung Maturation

In case of threatening preterm birth, it is standard to recommend treatment with betamethasone to accelerate fetal lung maturation. In pregnant women with diabetes, treatment with betamethasone can lead to significant hyperglycemia, which may cause hypoglycemia in the neonate. Changes in blood glucose in non-diabetic women are less investigated. In this study we aim to examine changes in maternal blood glucose levels in non-diabetic women, during treatment with betamethasone, by continuous glucose monitoring.

Hypotheses:

Administration of betamethasone induce significant hyperglycemia in non-diabetic pregnant women during treatment.

Study Overview

• Status: Recruiting
• Conditions: Hyperglycemia; Preterm Birth; Neonatal Hypoglycemia; Threatened Preterm Labor

Detailed Description

Antenatal corticosteroid administration is an important treatment to reduce the incidence of neonatal respiratory distress syndrome, and improve neonatal outcomes of babies born premature.

Administration of betamethasone however also affects the maternal glucose homeostasis, and it is well-known that in pregnant women with diabetes, the administration of glucocorticoids can lead to significant maternal hyperglycemia, and hypoglycemia in the neonate, unless the insulin dosage is adjusted accordingly. Administration of betamethasone also affects the glucose homeostasis in pregnant non-diabetic women. However, only few studies have investigated the changes in the blood glucose levels in non-diabetic pregnant women, and a more accurate depiction of the glycemic response to betamethasone can be obtained by continuous glucose monitoring.

Recruitment of participants will occur upon their arrival with symptoms of threatened preterm birth, when it is decided to start treatment with betamethasone for fetal lung maturation.

To measure blood glucose levels in the pregnant women, a continuous glucose monitor (CGM) will be used.

Further, blood samples will be collected on days 1-6 after inclusion, for measurement of: Insulin, blood glucose, 3-hydroxybutyrat, HgbA1c, CRP and leucocytes.

Urine dipstick test for ketones and glucose will be performed twice daily. After delivery, a blood sample will be extracted from the umbilical cord for measurement of Ph, base-excess, glucose, insulin c-peptide and inflammatory markers.

Information on hypoglycemia and/or the need for early feeding of the infant after birth will be recorded.

Perspectives:

The results of this study will help us understand how the administration of betamethasone affects maternal blood glucose levels. If it is found, that administration of betamethasone causes significant hyperglycemia in the pregnant women, it may be important to measure and treat hyperglycemia during betamethasone treatment, to ensure the effect of betamethasone and prevent neonatal complications due to hypoglycemia.

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Victoria Bøttker; Phone Number: +45 21253835; Email: victoria.boettker@gmail.com
• Study Contact Backup: Name: Puk Sandager, MD, PhD; Phone Number: 24216026; Email: kirssand@rm.dk

Study Locations

• Denmark
  • Central Region Denmark
    • Aarhus, Central Region Denmark, Denmark, 8200
      • Recruiting
      • Aarhus University Hospital
      • Contact: Puk Sandager, MD, Phd; Phone Number: 0045 + 24216026; Email: kirssand@rm.dk
      • Contact: Per Glud Ovesen, MD, DMSci, Professor; Phone Number: 0045 +´61669728 /78453315; Email: perovese@rm.dk
      • Contact: Victoria Bøttker, Medical student
      • Contact: Puk Sandager, MD, PhD
      • Contact: Per Glud Ovesen, MD, DMSci

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women admitted with symptoms of threatened preterm birth in gestational week 24+0 - 34+0

Description

Inclusion Criteria:

• Pregnant in gestational week 24+0 - 34+0 admitted with symptoms of threatened preterm birth:

  • Premature contractions and shortening of the cervix, or
  • Preterm premature rupture of membranes.
• Treatment with betamethasone for fetal lung maturation is planned, or started (maximum 4 hours before inclusion)
• Age over 18 years
• Read and understand Danish

Exclusion Criteria:

• Multiple pregnancy
• Diabetes
• Pre-existing maternal use of medications that affect glucose metabolism

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal blood glucose levels before, under and after the administration of betamethasone	Blood glucose levels (mmol/L) will be measured continuously using a continuous glucose monitor including a small electrode under the skin	7-14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of insulin (pmol/L)in maternal blood before, during, and after the effect of betamethasone	Blood samples will be collected on days 1-6, where day 1 is the day where the first dose of betamethasone is given.	7 days. From the day betamethasone is given untill 6 days after the first dose
The level of 3-hydroxybuturat (mmol/L) in maternal blood before, during and after treatment with Betamethasone	Blood samples will be collected on days 1-6, where day 1 is the day where the first dose of betamethasone is given.	7 days. From the day betamethasone is given untill 6 days after the first dose
Level of leukocytes (White blood cell count) (mia/L) in maternal blood before, during and after treatment with betamethasone	Blood samples will be collected on days 1-6, where day 1 is the day where the first dose of betamethasone is given.	7 days, from day one (the day where the first dose of betamethasone is given) untill 6 days after the first dose.
The level of CRP (C-reactive protein)(nmol/ml) in maternal blood before, during and after treatment with betamethasone	Blood samples will be collected on days 1-6, where day 1 is the day where the first dose of betamethasone is given.	7 days. From the day betamethasone is given untill 6 days after the first dose.
The level of glucose (mmol/L) in umbilical cord blood at delivery	After the birth and cord occlusion a blood sample will be drawn from the umbilical cord	At delivery of the baby
The level of insulin (pmol/L) in umbilical cord blood at delivery	After the birth and cord occlusion a blood sample will be drawn from the umbilical cord	At delivery
The level of c-peptid (pmol/L) in umbilical cord blood at delivery	After the birth and cord occlusion a blood sample will be drawn from the umbilical cord	At delivery
The level af adiponectin (ug/ml) in umbilical cord blood at delivery	After the birth and cord occlusion a blood sample will be drawn from the umbilical cord	At delivery
The level of leptin (ng/ml) in umbilical cord blood at delivery	After the birth and cord occlusion a blood sample will be drawn from the umbilical cord	At delivery
Number of infants with need for early feeding (yes/no) after birth	Information from files on whether the infant was given "Early feeding" after delivery (yes/no)	First two days after birth

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Continuous glucose monitoring; Preterm birth; Betamethasone; Antenatal corticosteroids
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Obstetric Labor Complications; Pregnancy Complications; Glucose Metabolism Disorders; Premature Birth; Hypoglycemia; Hyperglycemia; Obstetric Labor, Premature
• Other Study ID Numbers: 2024_VB_CGM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No